Left Atrial Distensibility to Predict Prognosis in Consecutive Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Kaohsiung Veterans General Hospital..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:
NCT01171040
First received: July 23, 2010
Last updated: March 7, 2011
Last verified: July 2009
  Purpose

Left ventricular filling pressure (LVFP) has prognostic significance in patients with heart failure. Traditionally, it should be assessed by invasive method, as cardiac catheterization and Swan-Gung catheter. In advance of new techniques and modality, echocardiography provides some useful parameters for assessing LVFP, such myocardial tissue Doppler imaging. Many articles had documented that peak velocity of early-diastolic trans-mitral inflow velocity divided by early-diastolic velocity over mitral annulus correlated closely to LVFP. However, myocardial tissue Doppler only provides the information of regional myocardium, so patients with regional wall motion abnormality, as coronary artery disease, can't be assessed by this method without handicap. In addition, conduction disturbance, like bundle branch block, also influences the result of myocardial tissue Doppler. For resolving those problems, the investigators had designed a new global parameter to assess LVFP. In the investigators prior study, left atrial distensibility correlated logarithmically to LVFP in patients with severe mitral regurgitation and also in patients with acute myocardial infarction. Left atrial distensibility provided a new viewpoint to assess left ventricular diastolic function and to predict prognosis. This time, to extend left atrial distensibility to general population received echocardiographic examination for predicting prognosis is attempted.


Condition Intervention
Heart Failure
Atrial Fibrillation
Stroke
Other: Echocardiography, including the measurements of left atrial (LA) distensibility

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Studies on Assessment of Left Atrial Distensibility to Predict Late Prognosis in Consecutive Patients Received Echocardiographic Examination

Resource links provided by NLM:


Further study details as provided by Kaohsiung Veterans General Hospital.:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    All cause mortality and heart failure with re-hospitalization were defined as hard cardiovascular event.

  • Heart failure with hospitalization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Heart failure with re-hospitalization is documented by at least one of the following: worse exercise tolerance and respiratory distress with NYHA class III or IV symptoms, presence of pulmonary rales, or chest radiography showing pulmonary congestion, which needs an augmented decongestive regimen with oral or intravenous medications during an in-hospital stay.


Secondary Outcome Measures:
  • Atrial fibrillation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Enrolled patients with intermittent tachycardia will receive Holter's EKG. Any events of atrial fibrillation documented by EKG or Holter, either paroxysmal or persistent, are accounted.

  • Stroke [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Stroke is defined as a sudden onset of focal neurological deficit more than 24 hours and confirmed by brain computed tomography or magnetic resonance imaging. Trans-esophageal echocardiography is suggested to clarify whether cardiogenic or not for all patients with stroke.


Estimated Enrollment: 2000
Study Start Date: July 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Consecutive patients received echocardiographic examinations
Consecutive patients received echocardiography are willing to participate in this study.
Other: Echocardiography, including the measurements of left atrial (LA) distensibility
The LA volumes were measured at three points: 1) immediately before the mitral valve opening (maximal LV volume or Volmax); 2) at onset of the P-wave on electrocardiography (pre-atrial contraction volume or Volp); and 3) at mitral valve closure (minimal LV volume or Volmin). The LA distensibility was calculated as (Volmax - Volmin)x 100% / Volmin. The LA ejection fraction was calculated as (Volp - Volmin)x 100% / Volp. In all patients, LA volumes were indexed to body surface area (BSA).

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Consecutive patients received echocardiographic examinations

Criteria

Inclusion Criteria:

  • consecutive patients received echocardiographic examination are willing to participate in this study.

Exclusion Criteria:

  • (1) patients with prosthetic mitral valves, or mitral stenosis
  • (2) rhythm other than sinus rhythm
  • (3) age less than 18 years-old
  • (4) inadequate image quality
  • (5) lack of informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01171040

Contacts
Contact: Jong-Khing Huang, MD 886-7-3422121 ext 1518 irb@vghks.gov.tw

Locations
Taiwan
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung, Taiwan, 886
Contact: Jong-Khing Huang, MD    886-7-3422121 ext 1518    irb@vghks.gov.tw   
Contact: Shih-Hung Hsiao, MD    886-7-3422121 ext 2011    a841120@kimo.com   
Principal Investigator: Jong-Khing Huang, MD         
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
Principal Investigator: Shih-Hung Hsiao, MD Cardiovascular Center, Department of Internal Medicine, Kaohsiung Veterans General Hospital
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jong-Khing Huang, MD, Current Superintendent of Kaohsiung Veterans General Hospital, Kaohsiung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01171040     History of Changes
Other Study ID Numbers: VGHKS99-015
Study First Received: July 23, 2010
Last Updated: March 7, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Kaohsiung Veterans General Hospital.:
left atrial distensibility
mortality
heart failure
atrial fibrillation
stroke
prognosis

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Failure
Stroke
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 25, 2014